Infant Diet Effects on Brain Function and Language Processing (fMRI)

• Sponsor: Arkansas Children's Hospital Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00735423
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 190
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to identify neurocognitive functions and language processing of 8-year-old children who were fed either breast milk, milk-based formula or soy-based formula during the first year of life.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: No intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures
• Actual Study Start Date: Aug 1, 2008
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No groups IDE used for outcome measurement not intervention	Device: No intervention; IDE used for outcome measurement not intervention

Outcome Measures

Primary Outcome Measures

1. Brain function test [8 year old]

2. Language processing tests [8 year old]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 90 Months to 101 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy 8-year-old children

• Full term

• Birth weight between the 5th - 95th weight-for-age

• Use of Breast milk, milk-based formula or soy-based formula throughout first year of life

• English as primary language

• Right handed first visit

• BMI between 5th - 95th percentile-for-age

Exclusion Criteria:

• Children with sleep disorders

• Children who use certain medications that may interfere with study assessments

• Illnesses or diseases or conditions that may interfere with study assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Nutrition Center	Little Rock	Arkansas	United States	72202

Sponsors and Collaborators

• Arkansas Children's Hospital Research Institute

Investigators

• Principal Investigator: Xiawei Ou, Ph.D., Arkansas Children's Nutrition Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arkansas Children's Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT00735423
• Other Study ID Numbers: 77556
• First Posted: Aug 15, 2008
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Keywords provided by Arkansas Children's Hospital Research Institute: Healthy children; Brain Function; Diet; Nutrition; Language; fMRI; ERP; Behavior

Study Results

No Results Posted as of Aug 5, 2022